Actively Recruiting
Phase 4 Study to Assess Valbenazines Effectiveness for Adults with Tardive Dyskinesia Who Are Symptomatic While Using or After Stopping VMAT2 Inhibitors
Led by Neurocrine Biosciences · Updated on 2026-06-16
50
Participants Needed
22
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of valbenazine in adults who have tardive dyskinesia TD and remain symptomatic while receiving or after stopping treatment with a vesicular monoamine transporter 2 VMAT2 inhibitor. The study focuses on both clinician- and patient-reported outcomes to better understand how valbenazine may impact TD symptoms. It is a Phase 4, open-label study sponsored by Neurocrine Biosciences. Participants will receive valbenazine capsules orally once daily for 24 weeks. The study involves a single treatment group with no placebo or comparator group. Valbenazine dosing and administration will be monitored throughout the 24-week treatment period. Participants will be assessed at baseline and at Week 24 for changes in abnormal involuntary movements using the Abnormal Involuntary Movement Scale AIMS. Additional evaluations include the Clinical Global Impression of Severity for TD, the Tardive Dyskinesia Impact Scale, and quality of life measures such as the EuroQol-Visual Analogue Scale. The study will monitor safety and efficacy over the 24 weeks of treatment, with total participation lasting approximately this duration.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Research Team
N
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